Kornimate/medical-research-clean huggingface dataset:
playmaker 3d printed knee extender

Conditions: ACL; ACL Injury

Summary: the purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an acl rupture before surgery.

the proposed study will assess the efficacy of utilizing desktop 3dp for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. if the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, pts, and providers. the study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3dp. this technology is an under- utilized resource; further research into the applications of 3dp in the field of orthopaedics will provide opportunities to improve patient care and outcomes.

Eligibility criteria:
inclusion criteria: * 14-60 years old patients who have suffered an isolated primary acl rupture exclusion criteria: * patients who have already attained full knee extension * open skin wounds that would come into contact with the device * pregnant women

Keywords: desktop 3d printing knee extender pre-habilitation
open-label extension of the dose finding study (dsc/08/2357/36) in patients with poly juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: primary objective of the study: the purpose of this extension study was to determine the safety of givinostat in a long term treatment of patients who participated in dsc/08/2357/36 study with good results (clinical benefit at least pediacr30 response);

givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular jia through the inhibition of the production/release of pro-inflammatory cytokines, such as il-1β, il-6 and tnfα, which are involved in the pathogenesis of the arthritic process.

Eligibility criteria:
inclusion criteria: * subjects who had successfully completed the previous dose finding study and were fully compliant to the inclusion/exclusion criteria described in the previous dsc/08/2357/36 exclusion criteria: * patients with fever related to jia or other systemic features of jia during 12 months before entering the study * active bacterial or mycotic infection requiring antimicrobial treatment * episode of macrophage activation syndrome over the last 6 months * baseline prolongation of qt/qtc interval, use of concomitant medications that prolong the qt/qtc interval or history of additional risk factors for tdp. * clinically significant cardiovascular disease * clinically significant illness i.e. any condition that in the opinion of the investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study * psychiatric illness/social situation that would limit compliance with study medication and protocol requirements * inherited metabolic diseases * presence of malignancy * pregnancy or lactation * positive blood test for hiv * active ebv infection, active b and/or c hepatitis * platelet count \<100x10(9)/l

Keywords: jia
sms reminders for positive fobt follow-up

Conditions: Colorectal Cancer

Summary: a randomized controlled trial to examine the effect of 3 mobile telephone text message reminders on followup colonoscopy 120 days after a positive fecal occult blood test among meuhedet members aged 50-74 who tested positive in 2016.

background: fecal occult blood tests are recommended by the us preventive services task force as a screening method for colorectal cancer, but they are only effective if positive results are followed by colonoscopy. surprisingly, a large proportion of patients with a positive result do not follow this recommendation. objective: to examine the effectiveness of a short message service in increasing adherence to colonoscopy follow-up after a positive fecal occult blood test. methods: this randomized controlled trial was conducted with patients who had positive colorectal cancer screening results. randomization was stratified by residential district and socioeconomic status. subjects in the control group (n = 238) received routine care that included an alert to the physician regarding the positive fecal occult blood test result. the intervention group (n = 232) received routine care and three short message service reminders to visit their primary care physician. adherence to colonoscopy was measured 120 days from the positive result. all patient information, including test results and colonoscopy completion, were obtained from their computerized medical records. physicians of the study patients completed an attitude survey regarding fobt as a screening test for colorectal cancer. the intervention and control groups were compared using chi-squared for discrete variables. logistic regression was used to calculate odds ratios and 95% confidence intervals for performing colonoscopy within 120 days, adjusting for potential confounders of age, gender, socioeconomic status, district, ethnicity, intervention group and physician's attitude.

Eligibility criteria:
inclusion criteria: * positive fecal occult blood test (fobt) in 2016 * agreed to receive sms from healthcare provider exclusion criteria: * existing oncology diagnosis * personal or family history of colorectal cancer * colonoscopy up to 10 years prior to fobt
sitagliptin (mk-0431) vs. placebo in patients with inadequate glycemic control on metformin with pioglitazone (mk-0431-128)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will examine the safety and efficacy of the addition of sitagliptin (mk-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.


Eligibility criteria:
inclusion criteria: * has type 2 diabetes and is at least 18 years of age and no older than 78 years of age * is male or is a female who is unlikely to conceive children * is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin or metformin and a sulfonylurea agent exclusion criteria: * has type 1 diabetes * has taken a dipeptidyl peptidase (dpp-4) inhibitor or a glucagon-like peptide-1 (glp-1) analogue * is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening * has had surgery within 30 days of screening or has major surgery planned during the study * is on or is likely to require treatment with corticosteroids for more than 2 weeks * has a history of active liver disease, including hepatitis b or c, cirrhosis, or gallbladder disease * is human immunodeficiency virus (hiv) positive * has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening * has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening * has severe active peripheral vascular disease * has a history of cancer or blood disorder * is pregnant or breast feeding
perinatal outcomes following change in clinical criteria in for treatment of maternal hypertension

Conditions: Maternal Hypertension

Summary: the purpose of this study is observe outcomes before and after a change in clinical practice in the threshold for management of severe hypertension in pregnancy and the post-partum period. outcomes will be observed for 10 months under the current (traditional) clinical blood pressure threshold for acute treatment of hypertension, which is \>= 160 millimeters of mercury (mmhg) systolic blood pressure (sbp). this will be followed by one month of education about rationale for the new sbp threshold of \>= 180 mmhg and change of clinical guidelines. then, there will be 10 months of observation after adopting the updated clinical threshold for acute antihypertensive treatment (\>= 180 sbp).


Eligibility criteria:
inclusion criteria: * any individual \> 20 weeks' gestation in triage or admitted at children's memorial hermann hospital (cmhh) and with blood pressure with \>= 160/110 mmhg exclusion criteria: * active seizure, stroke, congestive heart failure (chf)/pulmonary edema, acute kidney injury (aki), or myocardial infarction (mi) * a history of stroke, chf, chronic kidney disease (ckd), mi * have hemolysis, elevated liver enzymes, low platelets (hellp) syndrome or thrombocytopenia (platelets \< 100×10\^9/l) * persistent neurologic symptoms including headache \>8/10 one hour after analgesic or blurry vision/loss of vision
ml decision model for g-nec adjuvant therapy

Conditions: Gastric Neuroendocrine Carcinoma (G-NEC); Postoperative Adjuvant Therapy for G-NEC; Survival Outcomes; Machine Learning

Summary: gastric neuroendocrine carcinoma (g-nec) is a rare and aggressive tumor originating from neuroendocrine cells in the stomach lining. it is characterized by a high propensity for recurrence and a generally poor prognosis. due to its rarity, there is limited data and no established consensus on the optimal postoperative adjuvant therapy, making treatment decisions challenging for healthcare providers. this study is a retrospective analysis focusing on evaluating survival rates, identifying prognostic factors, and formulating treatment recommendations for patients with g-nec. by analyzing real-world clinical data, we aim to better understand the factors that influence patient outcomes and to develop evidence-based strategies for improving survival. our goal is to provide clinicians with valuable insights and tools to make more informed treatment decisions, ultimately enhancing the quality of care and outcomes for patients with this challenging disease.


Eligibility criteria:
inclusion criteria: * (1) patients who underwent radical surgery without any neoadjuvant therapy; * (2) pathology confirmed nec or mixed adenoneuroendocrine carcinoma (manec). exclusion criteria: * (1) history of other malignant neoplasms; * (2) treatment with endoscopic submucosal dissection or endoscopic mucosal resection or thoracotomy; * (3) incomplete clinical data (including pathological, adjuvant chemotherapy, and follow-up information); * (4) receipt of alternative adjuvant treatment regimens; * (5) death within 30 days postoperatively.

Keywords: gastric neuroendocrine carcinoma (g-nec) adjuvant chemotherapy machine learning decision support model random survival forest
implementing artificial-intelligence wristbands to help in recording seizures

Conditions: Epilepsy

Summary: the investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband embrace

currently, seizure tracking relies on subjective patient and family recall. in several studies patients report only approximately half of their seizures, and even less during sleep. sudden unexplained death in epilepsy (sudep) is the cause of premature death of up to 17% of all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as high as 1% per year). its etiology is probably due to peri-ictal respiratory, cardiac, or autonomic nervous system dysfunction. wristband sensors help caregivers assist patients during seizures and may reduce risks for complications such as injuries and sudep. accurate seizure detection may improve the quality of life (qol) of subjects and caregivers by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the home setting. possible risks are occurrence of alarm fatigue and invasion of privacy. the wristband embrace has an overall sensitivity of 89.1% and an overall specificity of 93.1%. the investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband embrace. methods: when the smart wristband detects the seizure, the mobile phone sends a text message to the companion and the nurse, the latter will see or get in touch with the companion and keep a record. in-patients receiving video-electroencephalography (veeg) exam use embrace during the veeg recording which usually takes 3-5 days. out-patients use embrace for 8 weeks. the investigators will enroll 30-50 patients, half in-patients and half out-patients. the benefits are evaluated in terms of satisfaction. .

Eligibility criteria:
inclusion criteria: * at least one seizure per month in the 3-month period before entering the study exclusion criteria: * uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or lung disorder, rapid progressive brain disorder, life-terminal disease, severe infection/ bleeding/ liver/ kidney disorder, platelet \<80,000/μl, neutrophil \<1,000/μl, clinically significant ecg abnormality, unstable psychiatric disease (except anxiety).
a study of 6(s)-5-mthf among serotonin reuptake inhibitor(ssri)-resistant outpatients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the purpose of the study is to test whether oral 6(s)-5-mthf (deplin®) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (ssris).

the study consists of two sequential phases, each lasting a total of four weeks (8 weeks total), with visits every 10 days. once patients agree to participate in the study by signing the informed consent document, a full medical and psychiatric history will be taken and a physical examination and blood draw will be performed. screen rating scales will be performed. screened and eligible patients will be asked to return two weeks later for a baseline visit when they will be randomized to double-blind treatment with placebo or deplin (6(s)-5-mthf). the double-blind treatment will last 60 days, during which patients will be seen every 10 days. subjects will be randomized to one of three treatment groups: a)deplin/deplin, b) placebo/deplin, c) placebo/placebo. patients will have a greater than 50% chance of receiving active medication (deplin) at some point in the 8 week study * for patients randomly assigned to the deplin/deplin sequence, the dose of 6(s)-5-mthf will be 7.5 mg/day during the first phase of the study, and 15 mg/d during the second phase of the study. * for patients randomly assigned to the placebo/deplin sequence, the dose of 6(s)-5-mthf will be 7.5 mg/day during the second phase of the study. * for patients randomly assigned to the placebo/placebo sequence, both tablets of study medication will be placebo during both phases of the study. all patients will be asked to take two tablets of blinded study medication in the morning, in addition to their stable dose of ongoing ssri treatment. each study medication tablet will be either 7.5 mg of 6(s)-5-mthf or matching placebo.

Eligibility criteria:
inclusion criteria: * 18-65 years old * meet criteria for current major depressive disorder * currently taking an ssri exclusion criteria: * pregnant women * unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease. * prior course of mthf augmentation, or intolerance to mthf at any dose * substance use disorders active within the last six months, any bipolar disorder (current or past), or any psychotic disorder (current or past). * have failed more than 2 adequate antidepressant trials during the current major depressive episode.
construct validity of a diagnostic hysteroscopy training model

Conditions: Menorrhagia

Summary: in a prospective case-control study, the investigators compare the objective structured assessment of technical skills (osats) scores in medical students and gynecologic experts performing a hysteroscopy on a training model for diagnostic hysteroscopy. the investigators hypothesize that osats on a hysteroscopy training model has construct validity to discriminate between experts and novices.

in a prospective case-control study, 140 medical students (,novices') and 10 senior gynecologists (,experts') will watch a demonstration detailing how to perform a hysteroscopy on a training model. all probands will perform a hysteroscopy themselves within 1 hour after the demonstration. their performance will be judged using an objective structured assessment of technical skills (osats) assessment. using metrical and non-metrical measurements, construct validity of the hysteroscopy training model to distinguish between experts and novices will be assessed. secondary endpoints are differences in osats scores within the group of novices based on gender and handyness, as well as satisfaction of the novices with the learning experience.

Eligibility criteria:
inclusion criteria: * medical student * no previous experience in gynecologic surgery * no previous gynecologic surgery training * gynecologist with a personal history of at least 50 hysteroscopies) exclusion criteria: * language barrier * unwillingness to participate
gene-environment interactions and brain functional connectivity in attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the aims of the current study are to examine gene-environment interactions associated with norepinephrine (ne) system genes (adra2a, slc6a2) in adhd, and to evaluate whether genetic changes in norepinephrine pathway are associated with differences in functional connectivity of white matter fiber tracts, as measured by diffusion tensor imaging (dti). furthermore, this study aims to examine neurobiological markers, such as intermediate neuroimaging phenotypes or neuropsychological endophenotypes associated with the pathophysiology of adhd. through evaluating drug responses and side effects with the associated measures of clinical, neuropsychological and neuroimaging characteristics, investigators would like to investigate predictors of treatment response associated with ne system genes in adhd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of attention-deficit hyperactivity disorder * 6-18 years old exclusion criteria: * history of neurological diseases, including convulsive disorders or brain damage * iq below 70 * pervasive developmental disorder (autism) * language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression). * tourette's syndrome * bipolar disorder * psychosis

Keywords: adhd adra2a methylphenidate response
oral nemonoxacin in treating elderly patients with cap

Conditions: Community-acquired Pneumonia

Summary: this study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (cap).


Eligibility criteria:
inclusion criteria: * age ≥65 years * clinical diagnosis of cap * evidence of inflammatory exudates or infiltrates on chest x-ray exclusion criteria: * suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia * history of hypersensitivity to quinolone or fluoroquinolone
a study of expiratory pressure modulation in moderate to severe copd patients - phase 1b

Conditions: Chronic Obstructive Pulmonary Disease

Summary: dynamic pulmonary hyperinflation (dh) and intrinsic positive end-expiratory pressure (peep) are well known problems in copd patients with acute and chronic respiratory failure. measurement of intrinsic peep level during both, invasive and non-invasive ventilation is of major importance since in some circumstances (e.g. during exercise or during exacerbations) it can significantly increase respiratory workload of copd patients. extrinsic peep applied during both, invasive and noninvasive ventilation is used to overcome intrinsic peep and therefore to avoid or reduce dynamic hyperinflation.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years who are contractually capable and mentally able to understand and follow the instructions of the study personnel 2. signed informed consent 3. moderate to severe copd patients (fev1/fvc ratio \ 45 mmhg) 4. currently using niv exclusion criteria: 1. acute exacerbation of copd, acute respiratory failure (ph \ 30/min) 2. unstable heart failure 3. cardiac failure with dehydration 4. pregnancy/breastfeeding women 5. pneumothorax/-mediastinum 6. increased risk of pneumothorax, pneumomediastinum or venous air embolism 7. in the opinion of the investigator, the patient is unsuitable for the study
rhenium-skin cancer therapy (sct) for the treatment of non-melanoma skin cancer.

Conditions: Non-melanoma Skin Cancer

Summary: efficacy of personalised irradiation with rhenium-skin cancer therapy (sct) for the treatment of non-melanoma skin cancer; a phase iv multi-centre, international, open label, single arm study.


Eligibility criteria:
inclusion criteria: 1. stage i or ii bcc or scc (scc well to moderately differentiated), and clinically node negative disease 2. confirmed histology, and with depth of lesion noted 3. subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.) 4. subjects able and willing to comply with the requirements of the study 5. age \>=18 years 6. informed consent signed by the subject consenting to undergo the study 7. lesions up to 8cm2 8. lesions with a depth up to 3mm confirmed on biopsy report and deemed appropriate clinically by treating clinician 9. subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician 10. patients who may have declined surgery and/or fractionated radiation therapy exclusion criteria: 1. inability to personally provide written informed consent or to understand and collaborate throughout the study 2. inability or unwillingness to comply with study requirements 3. prior treatment with surgery or radiation therapy for their target lesion(s) 4. depth of lesion greater than 3mm as defined by biopsy and/or clinical assessment 5. lupus and scleroderma 6. basal cell naevus syndrome, xeroderma, vitiligo and albinism 7. prior laser at the tumour site 8. malignant melanoma systemic therapy ongoing 9. any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry 10. a tumour affecting nerves or bony structures 11. clinical concern of metastatic disease 12. pregnancy and/or lactation 13. pathological exclusions: perineural invasion, lymphovascular invasion 14. anatomical exclusions: nmsc's of the medial canthus, eyelid margin (upper and lower), vermillion lip